Cardiovascular disease (CVD) is the leading cause of death globally. Each year in the U.S. there are 550,000 newly diagnosed CVD and there are 200,000 recurrent CVD events each year.
Currently, a primary method for treating or preventing CVD is use of statins to lower levels of cholesterol, more specifically low-density lipoprotein cholesterol (LDL-C). However, in 20% to 30% of CVD patients, statins are ineffective in preventing recurrent CV events. In a Mayo Clinic study and an unpublished recent European study, CVD patients treated with statins had a 6 to 20% second event rate within two years, even though these subjects experienced lowered LDL-C cholesterol levels following treatment with statins.
In the “Jupiter study” (Ridker P M, Danielson E, Fonseca F A H, Genest J, Gottto A M, Kastelein J J P, Koenig W, Libby P, Lorenzatti A J, MacFadyen J G, Nordestgaard B G, Shepherd J, Willerson J T, Glynn R J for the JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008; 359:2195-2207), subjects with elevated C-reactive protein (CRP) yet with low cholesterol levels were treated with high doses of the statin Crestor to determine whether the treatment reduced CRP and reduced first CVD events.
However, there exist subsets of CVD patients who respond (e.g., by lowering LDL-C cholesterol levels) to standard pharmacological treatments, yet remain susceptible to first or second recurrent CVD events. For example, in the JUPITER Study, of subjects treated with potent statin therapy, Lp(a) was a significant determinant of remaining risk for a first CVD event in spite of reduced LDL-C.
Accordingly, an unmet need exists for methods and kits to identify whether an individual who may be susceptible to recurrent CVD events—even with a standard pharmacological treatment—so that s/he can receive increased monitoring and/or be provided a more aggressive and optimal therapeutic intervention.